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FEMASYS INC
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FEMASYS INC
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FEMASYS INC
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2021-05-14
FEMASYS INC
References: March 26, 2021
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FEMASYS INC
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-05 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-20 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-19 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-19 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-12 | SEC Comment Letter | FEMASYS INC | DE | 377-08311 | Read Filing View |
| 2025-07-09 | SEC Comment Letter | FEMASYS INC | DE | 333-288527 | Read Filing View |
| 2023-12-06 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-12-05 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-12 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-07 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-05 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2022-07-07 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2022-07-06 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-05-14 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-03-26 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-03-10 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | SEC Comment Letter | FEMASYS INC | DE | 377-08311 | Read Filing View |
| 2025-07-09 | SEC Comment Letter | FEMASYS INC | DE | 333-288527 | Read Filing View |
| 2023-12-05 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-05 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2022-07-06 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-03-26 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-03-10 | SEC Comment Letter | FEMASYS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-05 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-20 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-19 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2025-08-19 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-12-06 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-12 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2023-07-07 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2022-07-07 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-06-15 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
| 2021-05-14 | Company Response | FEMASYS INC | DE | N/A | Read Filing View |
2025-12-05 - CORRESP - FEMASYS INC
CORRESP 1 filename1.htm FEMASYS INC. December 5, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-601 Attention: Re: Femasys Inc. Acceleration Request for Registration Statement on Form S-3 (333-288527) Dear Mr. O’Leary: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Femasys Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to December 9, 2025, at 9:00 a.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212) 641-5626. If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626. Sincerely, /s/ Kathy Lee-Sepsick Femasys Inc.
2025-08-20 - CORRESP - FEMASYS INC
CORRESP 1 filename1.htm Three Bryant Park 1095 Avenue of the Americas New York, NY 10036-6797 +1 212 698 3500 Main +1 212 698 3599 Fax www.dechert.com ANNA TOMCZYK anna.tomcyzk@dechert.com +1 202 641 5626 Direct +1 646 705 4971 Mobile August 20, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-601 Attention: Re: Femasys Inc. Acceleration Request for Registration Statement on Form S-1 Dear Mr. O’Leary: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Femasys Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to August 22, 2025, at 9:00 a.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Dechert LLP, Attention: Anna Tomczyk, by facsimile to (212) 698-3599. Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212) 641-5626. If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626. Sincerely, /s/ Kathy Lee-Sepsick Femasys Inc.
2025-08-19 - CORRESP - FEMASYS INC
CORRESP 1 filename1.htm Three Bryant Park 1095 Avenue of the Americas New York, NY 10036-6797 +1 212 698 3500 Main +1 212 698 3599 Fax www.dechert.com ANNA TOMCZYK anna.tomcyzk@dechert.com +1 202 641 5626 Direct +1 646 705 4971 Mobile August 19, 2025 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-601 Attention: Re: Femasys Inc. Acceleration Request for Registration Statement on Form S-1 Dear Mr. O’Leary: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Femasys Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to August 22, 2025, at 9:00 a.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Dechert LLP, Attention: Anna Tomczyk, by facsimile to (212) 698-3599. Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212) 641-5626. If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626. Sincerely, /s/ Anna Tomczyk Anna Tomczyk
2025-08-19 - CORRESP - FEMASYS INC
CORRESP 1 filename1.htm August 19, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Femasys Inc. Registration Statement on Form S-1 - Concurrence in Acceleration Request Ladies and Gentlemen: JonesTrading Institutional Services LLC (“ Jones ”) and Laidlaw & Company (UK) Ltd. (“ Laidlaw ”), acting as representatives of the underwriters for the offering pursuant to the registration statement on Form S-1 (the “ Registration Statement ”), hereby concur in the request by Femasys Inc. that the effective date of the above-referenced registration statement be accelerated to 9:00 A.M. (Eastern Time), or as soon as practicable thereafter, on August 22, 2025, pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Securities Act ”). Jones and Laidlaw affirm that they are aware of their obligations under the Securities Act in connection with this offering. Very truly yours, JONESTRADING INSTITUTIONAL SERVICES LLC By: /s/ Burke Cook Name: Burke Cook Title: General Counsel & Secretary LAIDLAW & COMPANY (UK) LTD. By: /s/ Luke Kottke Name: Luke Kottke Title: Head of Capital Markets
2025-08-12 - UPLOAD - FEMASYS INC File: 377-08311
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 12, 2025 Kathy Lee-Sepsick President and Chief Executive Officer Femasys Inc. 3950 Johns Creek Court, Suite 100 Suwanee, GA 30024 Re: Femasys Inc. Draft Registration Statement on Form S-1 Submitted August 8, 2025 CIK No. 0001339005 Dear Kathy Lee-Sepsick: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Nicholas O'Leary at 202-551-4451 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Anna Tomczyk, Esq. </TEXT> </DOCUMENT>
2025-07-09 - UPLOAD - FEMASYS INC File: 333-288527
July 9, 2025
Kathy Lee-Sepsick
President and Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, GA 30024
Re:Femasys Inc.
Registration Statement on Form S-3
Filed July 3, 2025
File No. 333-288527
Dear Kathy Lee-Sepsick:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Nicholas O'Leary at 202-551-4451 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Anna Tomczyk, Esq.
2023-12-06 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
December 6, 2023
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention:
Re:
Femasys Inc.
Acceleration Request for Registration Statement on Form S-3
File No. 333-275823
Dear Ms. Ansart,
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Femasys Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to December 8, 2023, at 9:00 a.m., Eastern Time, or as soon thereafter as
practicable, unless we or our outside counsel, Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its
responsibilities under the Act. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Dechert LLP,
Attention: Anna Tomczyk, by facsimile to (212) 698-3599.
Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212) 641-5626.
If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626.
Sincerely,
FEMASYS INC.
/s/ Kathy Lee-Sepsick
Kathy Lee-Sepsick
President and Chief Executive Officer
cc:
David S. Rosenthal, Dechert LLP
Anna Tomczyk, Dechert LLP
Dov Elefant, Femasys Inc.
2023-12-05 - UPLOAD - FEMASYS INC
United States securities and exchange commission logo
December 5, 2023
Kathy Lee-Sepsick
President and Chief Executive Officer
FEMASYS INC
3950 Johns Creek Court, Suite 100
Suwanee, Georgia 30024
Re:FEMASYS INC
Registration Statement on Form S-3
Filed November 30, 2023
File No. 333-275823
Dear Kathy Lee-Sepsick:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jessica Ansart at 202-551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Anna Tomczyk
2023-07-12 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
July 12, 2023
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention:
Jane Park and Katherine Bagley
Re:
Femasys Inc.
Acceleration Request for Registration Statement on Form S-1
File No. 333-272876
Dear Mrs. Park and Mrs. Bagley,
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Femasys Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to July 14, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel,
Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. We also respectfully
request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Dechert LLP, Attention: Anna Tomczyk, by facsimile to (212) 698-3599.
Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212)
641-5626.
If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626.
Sincerely,
FEMASYS INC.
/s/ Kathy Lee-Sepsick
Kathy Lee-Sepsick
President and Chief Executive Officer
cc:
David S. Rosenthal, Dechert LLP
Anna Tomczyk, Dechert LLP
Dov Elefant, Femasys Inc.
2023-07-07 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
July 7, 2023
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention: Jane Park
Katherine Bagley
Re:
Femasys Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 23, 2023
File No. 333-272876
Ladies and Gentlemen,
On behalf of our client, Femasys Inc.
(the “Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
relating to the Company’s Registration Statement on Form S-1 (the “Registration Statement”) contained in the Staff’s letter dated July 5, 2023 (the “Comment Letter”).
In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is filing Amendment No. 1 to the Registration Statement on Form S-1 (the “Amended Registration
Statement”) together with this response letter.
Set forth below are the Company’s
responses to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For convenience, the Staff’s comments are repeated below in bold
type, followed by the Company’s response to the comments as well as a summary of the responsive actions taken. We have included page numbers to refer to the location in the Amended Registration Statement submitted herewith where the
revised language addressing a particular comment appears. Capitalized terms used but not defined herein are used herein as defined in the Amended Registration Statement.
Page 2
Registration Statement on Form S-1 File June 23, 2023
Exhibits
1. Please revise the filing fee table to separately register the shares of common stock
issuable upon the exercise of common stock purchase warrants and placement agent warrants.
Response: The Company respectfully advises the Staff that it has revised the filing fee table included in the Amended Registration Statement.
2. We note your disclosure on the cover page that H.C. Wainwright & Co., LLC served
as your exclusive placement agent in connection with a private placement and registered direct offering completed on April 20, 2023. We also refer to the form of underwriting agreement with Chardan Capital Markets LLC filed as Exhibit 1.1 to your
registration statement. Please revise your exhibit index to remove this exhibit as it does not appear to be applicable to this offering. In addition, please file the placement agent agreement with H.C. Wainwright and the securities purchase
agreement(s) you entered into with certain institutional and accredited investors as exhibits to the registration statement.
Response: The Company respectfully advises the Staff that it has revised the exhibit index and associated exhibits of the Amended Registration
Statement. The Company respectfully advises the Staff that it did not enter into a Placement Agency Agreement with H.C. Wainwright & Co, LLC in connection with the private placement and registered direct offering.
General
3. We note your cover page disclosure that the last reported per share price of your
common stock on the Nasdaq Capital Market was $0.62 per share and your disclosure in the Form 8-K filed June 2, 2023 that you received notice from Nasdaq that you are not currently in compliance with its listing requirements. Please provide an
update on the status of this notice. Please revise your disclosure on the cover page, the summary, and risk factor sections to disclose the risks related to this notice and the risks of a potential delisting.
Response: The Company respectfully advises the Staff that it has revised the cover page, summary on page 3 and risk factors on page 4 to disclose the
risks related to this notice and the risks of a potential delisting.
Page 3
* * *
Please contact me at (212) 641-5626 if you have any questions regarding the foregoing
Sincerely,
/s/ Anna Tomczyk
Anna Tomczyk, Esq., Dechert LLP
cc: (via email)
Kathy Lee-Sepsick, Chief Executive Officer, Femasys Inc.
Dov Elefant, Chief Financial Officer, Femasys Inc.
2023-07-05 - UPLOAD - FEMASYS INC
United States securities and exchange commission logo
July 5, 2023
Kathy Lee-Sepsick
Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, Georgia 30024
Re:Femasys Inc.
Registration Statement on Form S-1
Filed June 23, 2023
File No. 333-272876
Dear Kathy Lee-Sepsick:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed June 23, 2023
Exhibits
1.Please revise the filing fee table to separately register the shares of common stock issuable
upon the exercise of common stock purchase warrants and placement agent warrants.
2.We note your disclosure on the cover page that H.C. Wainwright & Co., LLC served as
your exclusive placement agent in connection with a private placement and registered
direct offering completed on April 20, 2023. We also refer to the form of underwriting
agreement with Chardan Capital Markets LLC filed as Exhibit 1.1 to your registration
statement. Please revise your exhibit index to remove this exhibit as it does not appear to
be applicable to this offering. In addition, please file the placement agent agreement with
H.C. Wainwright and the securities purchase agreement(s) you entered into with certain
institutional and accredited investors as exhibits to the registration statement.
FirstName LastNameKathy Lee-Sepsick
Comapany NameFemasys Inc.
July 5, 2023 Page 2
FirstName LastName
Kathy Lee-Sepsick
Femasys Inc.
July 5, 2023
Page 2
General
3.We note your cover page disclosure that the last reported per share price of your common
stock on the Nasdaq Capital Market was $0.62 per share and your disclosure in the Form
8-K filed June 2, 2023 that you received notice from Nasdaq that you are not currently in
compliance with its listing requirements. Please provide an update on the status of this
notice. Please revise your disclosure on the cover page, the summary, and risk factor
sections to disclose the risks related to this notice and the risks of a potential delisting.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Jane Park at 202-551-7439 or Katherine Bagley at 202-551-2545 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Anna Tomczyk, Esq.
2022-07-07 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
July 7, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
RE:
Femasys Inc.
Registration Statement on Form S-3
File No. 333-266001
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Femasys Inc. (the “Registrant”) hereby respectfully requests, subject to telephone
confirmation, that the effectiveness of the above-captioned Registration Statement be accelerated so that it will become effective as of 4:00 p.m. EDT on July 12, 2022, or as soon thereafter as practicable, or at such later time as the Registrant
may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of David Rosenthal and Anna Tomczyk of Dechert LLP, counsel to the Registrant, to make such request on its behalf.
Very truly yours,
FEMASYS INC.
/s/ Dov Elefant
Dov Elefant
Chief Financial Officer
2022-07-06 - UPLOAD - FEMASYS INC
United States securities and exchange commission logo
July 6, 2022
Kathy Lee-Sepsick
President and Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, Georgia 30024
Re:Femasys Inc.
Registration Statement on Form S-3
Filed July 1, 2022
File No. 333-266001
Dear Ms. Lee-Sepsick:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David S. Rosenthal, Esq.
2021-06-15 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
June 15, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Femasys Inc.
Registration Statement on Form S-1
Registration No. 333-256156
Acceleration Request
Requested Date: June 17, 2021
Requested Time: 4:00 PM, Eastern Daylight Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Chardan Capital Markets, LLC, as representative of the several
underwriters, hereby join Femasys Inc. in requesting that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-1
(File No. 333-256156) (the “Registration Statement”) to become effective on June 17, 2021, at 4:00 PM, Eastern Daylight Time, or as soon as practicable thereafter.
Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to
underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended, to the extent applicable.
Very truly yours,
Chardan Capital Markets, LLC
By:
/s/ Shai Gerson
Name:
Shai Gerson
Title:
Managing Partner
2021-06-15 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
June 15, 2021
Office of Life Sciences
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Ada D. Sarmento
Celeste Murphy
Jenn Do
Kevin Vaughn
Re:
Femasys Inc.
Acceleration Request for Registration Statement on Form S-1
File No. 333-256156
Dear Ms. Virginio,
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Femasys Inc. (the “Company”) hereby requests that the
effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to June 17, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our
outside counsel, Dechert LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. We
also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Dechert LLP, Attention: Anna Tomczyk, by facsimile to
(212) 698-3599.
Once the Registration Statement is effective, please orally confirm the event with our counsel, Dechert LLP, by calling Anna Tomczyk at (212) 641-5626.
If you have any questions regarding this request, please contact Anna Tomczyk of Dechert LLP at (212) 641-5626.
Sincerely,
FEMASYS INC.
/s/ Kathy Lee-Sepsick
Kathy Lee-Sepsick
Chief Executive Officer
cc:
David S. Rosenthal, Dechert LLP
Anna Tomczyk, Dechert LLP
2021-05-14 - CORRESP - FEMASYS INC
CORRESP
1
filename1.htm
May 14, 2021
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jenn Do
Kevin Vaughn
Ada D. Sarmento
Celeste Murphy
Re:
Femasys Inc.
Amendment No. 1 to the Draft Registration Statement on Form S-1
Submitted on March 17, 2021
CIK No. 0001339005
Ladies and Gentlemen,
On behalf of our client, Femasys Inc. (the “Company”), we are responding to the comments from the Staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to the Company’s Amendment No. 1 to the Draft Registration Statement on Form S-1 (the “Draft Registration Statement”) contained in the Staff’s letter dated March 26, 2021 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the
Company has revised the Registration Statement and is filing a Registration Statement on Form S-1 (the “Registration Statement”) together with this response letter. The Registration Statement also contains
certain additional updates and revisions.
Set forth below are the Company’s responses to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff’s comments are repeated below in bold, followed by the Company’s response to the comments as well as a summary of the responsive actions taken. We have included page numbers to refer to the location in the Registration
Statement submitted herewith where the revised language addressing a particular comment appears. Capitalized terms used but not defined herein are used herein as defined in the Registration Statement.
Page 2
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your revisions in response to prior comment 1 that the FDA will evaluate the results of the small IDE clinical study that you are currently conducting to determine whether to allow you to move forward with a
pivotal trial. In the next paragraph, you state that if the FDA approves the IDE for the pivotal clinical trial, you will initiate a new pivotal trial. In your disclosure on page 13, you state that enrollment has been paused for the pivotal trial
until the FDA approves an IDE supplement to resume the study or an IDE for a new pivotal trial. Please revise to clarify that here, if true, as the disclosure currently appears to indicate that you would only be initiating a new pivotal trial and not
potentially continuing a paused trial.
Response: The Company respectfully advises the Staff that it has revised disclosure on pages 2, 14, 79 and 85 of the Registration Statement.
Financial Statements, page F-3
2. Given the automatic conversion upon the completion of this offering of all of your
convertible preferred stock into shares of common stock (pages 8, 62 and elsewhere), please tell us how you considered providing a pro forma presentation of the affected line items on the face of your balance sheet as
well as pro forma loss per share on the face of your statement of comprehensive loss. Also, revise to provide a related footnote discussion thereof.
Response: The Company reviewed the guidance in TOPIC 3 – Pro Forma Financial Information, Regulation S-X Article 11, Item 3430 – Other Changes in Capitalization At or Prior to Closing of an IPO, which
state:
3430.1 Generally, the historical balance sheet and statement of comprehensive income (including EPS) should not be revised to reflect modifications of the terms of outstanding securities that become effective after the
latest balance sheet date, although pro forma data may be necessary. Depending on the facts and circumstances, the staff may not object if the registrant and its independent accountants elect to present retroactively a conversion of securities as if
it had occurred at the date of the latest balance sheet included in the filing (with no adjustment of earlier statements). However, if the original instrument accrues interest or accretes toward redemption value after the balance sheet date until the
conversion actually occurs, or if the terms of the conversion do not confirm the carrying value, only pro forma presentation would be deemed appropriate.
3430.2 If terms of outstanding equity securities will change subsequent to the date of the latest balance sheet and the new terms result in a material reduction of permanent equity or, if redemption of a material amount
of equity securities will occur in conjunction with the offering, the filing should include a pro forma balance sheet (excluding effects of offering proceeds) presented alongside of the historical balance sheet giving effect to the change in
capitalization.
3430.3 If the conversion of outstanding securities will occur subsequent to the latest balance sheet date and the conversion will result in a material reduction of earnings per share (excluding effects of offering), pro
forma EPS for the latest year and interim period should be presented giving effect to the conversion (but not the offering).
Based upon the above guidance, the Company’s evaluation concluded that pro forma disclosure was not required under 3430.2 and 3430.3 for the following reasons:
•
The pro forma effect of the automatic conversion of all outstanding shares of our convertible preferred stock as of December 31, 2020 into 17,210,609 shares of our common stock immediately prior to the closing of the initial public
offering and the automatic conversion of all of our outstanding shares of redeemable convertible preferred stock as of December 31, 2020 into 55,835,833 shares of our common stock immediately prior to the closing of the initial public
offering would not result in a material reduction of permanent equity; rather, the Company’s permanent equity would increase on a pro forma basis; and
•
The pro forma basic and diluted net loss per share for the year ended December 31, 2020 would not result in a material reduction in earnings per share (excluding the effects of the offering); rather, the net loss per share would improve
on a pro forma basis.
* * *
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Please contact the undersigned at (212) 698-3616 if you have any questions regarding the foregoing.
Sincerely,
/s/ David S. Rosenthal
David S. Rosenthal
cc: Kathy Lee-Sepsick, Femasys Inc.
Thomas S. Levato, Goodwin Procter LLP
2021-03-26 - UPLOAD - FEMASYS INC
United States securities and exchange commission logo
March 26, 2021
Kathy Lee-Sepsick
Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, GA 30024
Re:Femasys Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted March 17, 2021
CIK No. 0001339005
Dear Ms. Lee-Sepsick:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your revisions in response to prior comment 1 that the FDA will evaluate the
results of the small IDE clinical study that you are currently conducting to determine
whether to allow you to move forward with a pivotal trial. In the next paragraph, you state
that if the FDA approves the IDE for the pivotal clinical trial, you will initiate a new
pivotal trial. In your disclosure on page 13, you state that enrollment has been paused for
the pivotal trial until the FDA approves an IDE supplement to resume the study or an IDE
for a new pivotal trial. Please revise to clarify that here, if true, as the disclosure currently
appears to indicate that you would only be initiating a new pivotal trial and not potentially
FirstName LastNameKathy Lee-Sepsick
Comapany NameFemasys Inc.
March 26, 2021 Page 2
FirstName LastName
Kathy Lee-Sepsick
Femasys Inc.
March 26, 2021
Page 2
continuing a paused trial.
Financial Statements, page F-3
2.Given the automatic conversion upon the completion of this offering of all of your
convertible preferred stock into shares of common stock (pages 8, 62 and elsewhere),
please tell us how you considered providing a pro forma presentation of the affected line
items on the face of your balance sheet as well as pro forma loss per share on the face of
your statement of comprehensive loss. Also, revise to provide a related footnote
discussion thereof.
You may contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David S. Rosenthal, Esq.
2021-03-10 - UPLOAD - FEMASYS INC
United States securities and exchange commission logo
March 10, 2021
Kathy Lee-Sepsick
Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, GA 30024
Re:Femasys Inc.
Draft Registration Statement on Form S-1
Submitted February 12, 2021
CIK No. 0001339005
Dear Ms. Lee-Sepsick:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your disclosure elsewhere in the prospectus regarding the FDA's safety concerns
with your pivotal trial for FemBloc that resulted in the trial being paused. Please revise to
disclose that here and the fact that enrollment is paused until the FDA either approves an
IDE supplement to resume the study or an IDE for a new pivotal trial. Please also revise
to disclose that the small IDE study that began in June 2020 is being used to evaluate the
adequacy of certain proposed mitigations as a result of the FDA's safety concerns.
FirstName LastNameKathy Lee-Sepsick
Comapany NameFemasys Inc.
March 10, 2021 Page 2
FirstName LastNameKathy Lee-Sepsick
Femasys Inc.
March 10, 2021
Page 2
Risks Associated With Our Business, page 4
2.Please revise to disclose the risk that the FDA may not allow you to continue the pivotal
trial for FemBloc due to safety concerns.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company, page 6
3.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risk Factors
We face the risk of product liability claims that could be expensive, divert management's
attention and harm our reputation and business, page 26
4.We note your disclosure here that the FemBloc system has shown a "favorable safety
profile" to date. Safety is a conclusion that is solely within the authority of the FDA or
comparable regulatory bodies. Please remove or revise this statement accordingly.
Business
Intellectual Property, page 89
5.Please revise to disclose the material foreign jurisdictions where you own patents or have
pending patent applications.
(2) Summary of Significant Accounting Policies, page F-9
6.Regarding item (i) on inventories on page F-10, you state that in 2019, you disposed of
inventory, primarily in connection with your FemCerv ® product, in the amount of
$29,401 and that as of December 31, 2019, the reserve for slow moving, obsolete, or
unusable inventories was $2,484. Please explain why this disposal was necessary, e.g.,
identify the raw materials or other components that expire, etc. Please explain why
FemCerv ® is not included in your product pipeline table on page 3 if it is cleared to
market in the U.S. and Europe (page 85). Finally, please identify the product(s) for which
the reserve for slow moving, obsolete, or unusable inventories is attributed and the
reason(s) such a reserve is warranted therefor.
7.You report a long-term Clinical Holdback liability of $145,768 as of December 31, 2019.
Please revise your footnotes to more clearly describe the nature of this liability, how it
was computed, and provide a rollforward of the balances for the periods presented.
FirstName LastNameKathy Lee-Sepsick
Comapany NameFemasys Inc.
March 10, 2021 Page 3
FirstName LastName
Kathy Lee-Sepsick
Femasys Inc.
March 10, 2021
Page 3
You may contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David S. Rosenthal, Esq.